2009 in Review This brief summary is provided to highlight some of the accomplishments in research that have occurred at Mercy Medical Center during the past year, and, in most cases, have been the result of collaborations among the partners of the ICTCR. This is not an exhaustive list and because most of the information presented here has had involved in some way the ICTCR. Other research occurring at Mercy Medical Center that does not appear on this list was not included here because it did not otherwise come directly to the attention of the ICTCR. Collaborations: Collaborative brain mapping in stroke patients involved an association between Ruan Neurology, MMC Radiology and DMU Anatomy Department. Completion of MRSA survey of clinic personnel in the Family Medicine Residency Program in collaboration with Dr. Jeffrey Gray at DMU using PCR techniques and advanced genotyping of strains was announced. Mercy Medical Center is continuing as a partner with University of Iowa and other health organizations in Polk County as a study site for the National Children’s Study which went into a quiescent mode during 2008-9, but is now open for startup as pilot recruiting centers on a competitive basis and MMC is participating in the effort to be awarded early startup. Mercy and DMU have developed a cancer proteomics program in collaboration with the lab of Dr. David Soll at the University of Iowa. The DMU lab obtains specimens from the Mercy Surgeons and the DMU lab serves as a beta test facility for obtaining unique proteome signatures from cancerous tissues. The Neonatal Intensive Care Unit at Mercy Medical Center will join as a satellite center with the University of Iowa in the Federally-sponsored Neonatal Research Network which includes only 16 centers nationwide. This program is the premier source of information on best practices for very low birth weight infants. The sponsoring agency is the Eunice Kennedy Shriver National Institute for Child Health and Human Development. A graduate from DMU was doing a research fellowship at the National Library of Medicine, and worked with Mercy physicians on a survey related to their use of highly condensed reports of journal articles.
New Research Undertaken: Iowa Diabetes and Endocrinology Research Center (IDERC) announced several new research efforts including a major research study, A Randomized Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Antihyperglycemic Therapy (TECOS) trial. Dean Meows, MD is beginning an inpatient therapy study for acute influenza patients. A collaborative study between Bala Napa, MD of the Pediatric ICU and students from the Drake Health Sciences program are investigating the relationship of arterial and venous blood gasses relative to outcomes of PICU patients. An investigator initiated study of microbial flora of pregnancy has begun and the analysis will involve molecular technologies to identify organisms independent of direct cultures. MIRIaM established as the informatics arm of the ICTCR, formalizing the ability to bring informatics assets to research programs in which Mercy is a collaborator. The first new informatics effort by MIRIaM is the development of a total joint registry. The Perinatal Center of Iowa became a study location for a national study jointly funded by NIH and Columbia Laboratories. This research will emphasize sonographically diagnosed sort cervix which is an established risk factor for premature birth. Treatment will be application of progesterone or placebo on a randomized basis. Mercy Clinics Inc. with the assistance of DMU and the ICTCR prepared a plan for systematic evaluation of the implementation of the patient centered medical home. Although this research has not been funded, it is ready for submission to an appropriate funding agency. Mercy Clinics have also been engaged in a project supported by the Foundation for Informed Medical Decision Making (FIMDM). This project is tied into their implementation and documentation of the Medical Home and deployment of Health Coaches The ICTCR with researchers located at Des Moines University have undertaken a scientifically founded evaluation of the Mercy Health Network. Surgery resident Matt Severeidt has begun a study of adipokines in patients who undergo bariatric surgery. A total joint replacement registry was begun in 2009 and will begin enrolling in 2010.
Publications (Manuscripts and Abstracts): Announced publication of article on stroke which was DMU-MMC Ruan collaboration. Albright et al in Journal of Stroke and Cerebrovascular Diseases 18; 2009 203-207. A collaborative paper by Drake University’s Geoff Wall, PharmD and Mercy’s Bernard Leman, MD was published in “Digestion”. A collaborative paper was published by the ICTCR with Bryan Folkers (surgery resident) as the first author. It appeared in the North American Journal of Medical Sciences (NAJMS). Two meeting presentations as a result of collaboration of DMU Human Performance Lab with Iowa Ortho physicians:
1. Vardaxis VG, Haden J, Singsank Z & Mahoney C (2009). Periarticular muscle co-activation in total knee arthroplasty patients and controls during gait. Gait & Posture 30(2): S21. 2. Vardaxis VG, Haden J, Singsank Z & Mahoney C (2009). Altered gait mechanics in knee osteoarthritis patients before and after surgery. Gait & Posture 30(2): S124-S125. 3. A third abstract has been submitted to the international Gait meeting in May 2010. Bryan Larsen, PhD (ICTCR Executive Director) has been named President of the International Infectious Diseases Society for Obstetrics and Gynecology (I-IDSOG-USA), and will edit a special issue of Infectious Diseases in Obstetrics and Gynecology. A DMU student and Mercy physicians will be presenting their experience with the use of CyberKnife® in treatment for small cell lung cancer.
Things that will facilitate research productivity: A new policy establishing the ICTCR and defining its purpose became part of Mercy Corporate Policies this year. A new corporate policy was developed during this year regarding research misconduct, its investigation and remediation. This is required for several Federal funding opportunities and allows us to remain qualified to receive funds. A proposal was developed to create a sponsored programs office at Mercy and to operate this office under the auspices of the ICTCR. The purpose is to facilitate the role of Mercy Foundation as a fiscal agent for research funds but to relieve the foundation of the burden of the administrative oversight of grant activities. A master agreement (contract) with a major contract research organization has made Mercy Medical Center a prime candidate for new sponsored clinical trials. As part of this contract, the research organization provides an onsite research coordinator, and we have developed a location for this individual to work from while serving the needs of Mercy projects awarded through the research organization. The ICTCR launched its website early in 2009 and will undergo an update and the placement of new information that will make it more useful to partners and visitors from anywhere in the world.
Meetings related to research: MIRIAM Colloquium in which a national audience of invitees met to discuss issues related to medical and research informatics and options for collaboration and productive future work in medical informatics. The Perinatal Center of Iowa (PCI) held a research-focused meeting on pregnancy and parturition. This event included national and international speakers with the possibility of generating international research opportunities. Several of the partners of the ICTCR have hosted scientific meetings over the past year, and as part of these meetings the role of ICTCR was presented to the attendees. The ICTCR and its functions were presented to the Mercy College of Health Sciences (MCHS) faculty retreat. A meeting was conducted with several representatives of a major pharmaceutical manufacturer, and plans for continued engagement that may support educational and research opportunities was placed before the company representatives. They are awaiting further information about our implementation of an arthroplasty registry. Presentation on clinical research was delivered to the incoming Drake Health Science class and collaborative opportunities presented. Regular meetings have been held with residents in surgery and family medicine programs to assist with development of individual and group research projects.
Institutional Review Board (IRB) The number of open studies changes with actions of the board and some of these occur at regularly scheduled meetings and some actions occur between meetings. That said, during the first week of January 2010, the Mercy Medical Center IRB showed 155 open protocols which is roughly 100 more open protocols than at this time last year. During the past year policies and procedures have been improved for certain aspects of the human subjects protection program. For example, the board adopted a policy that all investigators who undertake phase III or IV studies will need to complete a questionnaire that indicates that the study and its sponsor will comply with the Association of American Medical Colleges (AAMC) publishing guidelines. We have promulgated an affidavit that will be signed by students conducting research involving patient records. This document indicates the students have been briefed in data security issues that will allow them to remain in compliance with HIPAA, and their signature indicates that they will use personal computers, removable storage devices and other electronic or paper recording of information in a manner that is compliant with HIPAA regulations.
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